Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2013 |
End Date: | December 2014 |
A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin
Primary Objective:
- To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body
weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin
glargine ± metformin.
Secondary Objectives:
- To compare the treatments/regimens on:
- The percentage of patients reaching the target of HbA1c <7% or ≤6.5%
- Body weight
- Self-Monitored Glucose profiles
- Fasting Plasma Glucose (FPG)
- Post-prandial plasma glucose /glucose excursions during a standardized meal test
(subset of patients)
- Daily doses of insulins
- Safety and tolerability
- To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body
weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin
glargine ± metformin.
Secondary Objectives:
- To compare the treatments/regimens on:
- The percentage of patients reaching the target of HbA1c <7% or ≤6.5%
- Body weight
- Self-Monitored Glucose profiles
- Fasting Plasma Glucose (FPG)
- Post-prandial plasma glucose /glucose excursions during a standardized meal test
(subset of patients)
- Daily doses of insulins
- Safety and tolerability
Approximately 41 weeks including a 26 week treatment period
Inclusion criteria :
- Patients with type 2 diabetes mellitus diagnosed at least 1 year before screening
visit (V1) .
- Patients treated with basal insulin for at least 6 months.
- Patients treated for at least 3 months prior to visit 1 with a stable basal insulin
regimen (ie type of insulin and time/frequency of the injection). The insulin dose
should be stable (± 20 %) and ≥20 U/day for at least 2 months prior to visit 1.
- Patients treated with basal insulin alone or in combination with 1 to 3 oral
anti-diabetic drugs (OADs) that can be: metformin (≥1.5g/day or maximal tolerated
dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide.
The dose of OADs should be stable for at least 3 months prior to visit 1.
Exclusion criteria:
- At screening: age < legal age of majority
- At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone
or in combination with metformin only; < 7.0% and > 10.0% for patients treated with
basal insulin and a combination of oral anti-diabetic drugs which includes a SU
and/or a DPP-4 inhibitor and/or a glinide.
- Women of childbearing potential with no effective contraceptive method, pregnancy or
lactation
- Type 1 diabetes mellitus
- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria
within 3 months prior to screening.
- Previous treatment with short or rapid acting insulin other than in relation to
hospitalization or an acute illness.
- Any previous treatment with lixisenatide, or any discontinuation from another GLP-1
receptor agonist due to safety/tolerability issue or lack of efficacy.
- At screening, Body Mass Index (BMI) ≤20 or >40 kg/m².
- Weight change of more than 5 kg during the 3 months prior to the screening visit; use
of weight loss drugs within 3 months prior to screening.
- Within the last 6 months prior to screening: history of myocardial infarction,
stroke, or heart failure requiring hospitalization. Planned coronary, carotid or
peripheral artery revascularisation procedures.
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,
stomach/gastric surgery.
- At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure >
95 mmHg
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic
condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
- Contraindication related to metformin (for patient receiving this treatment), insulin
glargine, insulin glulisine or lixisenatide.
- Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or
end-stage renal disease.
- At screening, amylase and/or lipase > 3 times the upper limit of the normal
laboratory range (ULN)
- At screening ALT or AST>3ULN
- At screening calcitonin ≥20 pg/ml (5.9 pmol/L)
Exclusion Criteria for randomization at the end of the screening period before
randomization:
- HbA1c <7.0% or >9.0%.
- 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).
- Amylase and/or lipase > 3 times ULN.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
48
sites
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